4-Aminopyridine for Skin Wounds

Overseen By Andrea Horne

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: John Elfar

Must not be taking: Aminopyridines, OCT2 inhibitors

Disqualifiers: Neurological disorders, Seizure disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any aminopyridine medications, including other compounded 4-AP, and organic cat-ion transporter 2 (OCT2) inhibitors like Cimetidine.

How does the drug 4-Aminopyridine differ from other treatments for skin wounds?

4-Aminopyridine is unique because it is primarily known for its use in treating neurological conditions like multiple sclerosis, where it helps improve nerve signal conduction. Its application in skin wounds is novel, as it may offer a different mechanism of action compared to traditional antimicrobial or wound-healing agents, potentially enhancing nerve function and promoting healing in a way that other treatments do not. ^{1 2 3 4 5}

What is the purpose of this trial?

Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults. The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing. The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing.

Research Team

John Elfar, MD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for adults with chronic non-healing wounds or acute wounds. Participants should be in good health overall, aside from their wound condition.

Inclusion Criteria

Ability to give written informed consent

I can assess and report on my wound healing and any changes in feeling or movement.

I am healthy and do not have skin conditions on my underarm or upper inner arm.

Exclusion Criteria

Pregnancy, breastfeeding, or incarcerated individuals

Patients with a concomitant traumatic brain injury

Suspected renal impairment based on the Choyke questionnaire

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4-aminopyridine or placebo for wound healing

6 weeks

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 4-Aminopyridine

Trial Overview The study tests if 4-aminopyridine (4-AP), a new agent thought to be safe, can speed up the healing of wounds. Some participants will receive 4-AP while others will get a placebo for comparison.

Participant Groups

Group I: Group A: 4-aminopyridine Active Control 1 Intervention

dalfampridine (generic) 10 mg capsule po every 12 hours

Group II: Group B: Placebo Placebo Group 1 Intervention

Placebo-1 capsule po every 12 hours

Who Is Running the Clinical Trial?

John Elfar

Lead Sponsor

Trials

4

Recruited

500+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Turning a Collagenesis-Inducing Peptide Into a Potent Antibacterial and Antibiofilm Agent Against Multidrug-Resistant Gram-Negative Bacteria. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Hexadentate 3-hydroxypyridin-4-ones with high iron(III) affinity: design, synthesis and inhibition on methicillin resistant Staphylococcus aureus and Pseudomonas strains. [2015]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Prenylated Flavonoids in Topical Infections and Wound Healing. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Zinc Pyrithione Improves the Antibacterial Activity of Silver Sulfadiazine Ointment. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the Antimicrobial Peptide, RP557, for the Broad-Spectrum Treatment of Wound Pathogens and Biofilm. [2020]